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Clinical Impact of Second-look Endoscopy After Endoscopic Submucosal Dissection of Gastric Neoplasm (SLEGD)

Primary Purpose

Gastric Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
second look endoscopy
Sponsored by
Kosin University Gospel Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Neoplasms focused on measuring Endoscopic submucosal dissection, gastric neoplasm, second look endoscopy

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • histological confirmed patients(gastric adenoma or adenocarcinoma)
  • performed gastric ESD patients about 24 hours before

Exclusion Criteria:

  • perforation after ESD
  • piecemeal resection of ESD specimen
  • hemostatic agent or proton pump inhibitor users before ESD
  • heparin or antiplatelet agent users
  • Serious concurrent infection or nonmalignant illness that is uncontrolled
  • Psychiatric disorder that would preclude compliance
  • Allergy history to proton pump inhibitor

Sites / Locations

  • Kosin University Gospel HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Second look endoscopy

without second look endoscopy

Arm Description

This group is performed second look endoscopy about 24 hours later from endoscopic submucosal dissection.

This group is not performed second look endoscopy after ESD

Outcomes

Primary Outcome Measures

Post-ESD bleeding rate according to second look endoscopy

Secondary Outcome Measures

bleeding complication rate according to location of lesion in stomach.
Fundus, cardia, upper body, mid body, lower body, antrum anterior wall, posterior wall, great curvature, lesser curvature
Bleeding rate according to size of resected specimen
longest diameter of specimen: millimeter
Post ESD bleeding rate according to total procedure time of endoscopic submucosal dissection
Post ESD bleeding rate according to bleeding degree during endoscopic submucosal dissection
Mild: bleeding control time: <1/3 of total ESD procedure time. Moderate: bleeding control time: 1/3~1/2 of total ESD procedure time Severe: bleeding control time: >1/2 of total ESD procedure time

Full Information

First Posted
November 26, 2013
Last Updated
December 4, 2013
Sponsor
Kosin University Gospel Hospital
Collaborators
Inje University
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1. Study Identification

Unique Protocol Identification Number
NCT02005809
Brief Title
Clinical Impact of Second-look Endoscopy After Endoscopic Submucosal Dissection of Gastric Neoplasm
Acronym
SLEGD
Official Title
Clinical Impact of Second-look Endoscopy After Endoscopic Submucosal Dissection of Gastric Neoplasm
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kosin University Gospel Hospital
Collaborators
Inje University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Gastroenterologists often follow up second look endoscopy after endoscopic submucosal dissection(ESD) of gastric neoplasms because they want to prevent bleeding of procedure sites. But Goto suggested in his retrospective analysis that a second-look endoscopy after endoscopic submucosal dissection for gastric epithelial neoplasm may be unnecessary. So, the investigators try to identify the hypothesis prospectively in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Neoplasms
Keywords
Endoscopic submucosal dissection, gastric neoplasm, second look endoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
268 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Second look endoscopy
Arm Type
Active Comparator
Arm Description
This group is performed second look endoscopy about 24 hours later from endoscopic submucosal dissection.
Arm Title
without second look endoscopy
Arm Type
No Intervention
Arm Description
This group is not performed second look endoscopy after ESD
Intervention Type
Procedure
Intervention Name(s)
second look endoscopy
Intervention Description
Second look endoscopy includes observation or prophylactic bleeding control of ESD site.
Primary Outcome Measure Information:
Title
Post-ESD bleeding rate according to second look endoscopy
Time Frame
Up to 60days
Secondary Outcome Measure Information:
Title
bleeding complication rate according to location of lesion in stomach.
Description
Fundus, cardia, upper body, mid body, lower body, antrum anterior wall, posterior wall, great curvature, lesser curvature
Time Frame
Up to 60days
Title
Bleeding rate according to size of resected specimen
Description
longest diameter of specimen: millimeter
Time Frame
Up to 60days
Title
Post ESD bleeding rate according to total procedure time of endoscopic submucosal dissection
Time Frame
Up to 60days
Title
Post ESD bleeding rate according to bleeding degree during endoscopic submucosal dissection
Description
Mild: bleeding control time: <1/3 of total ESD procedure time. Moderate: bleeding control time: 1/3~1/2 of total ESD procedure time Severe: bleeding control time: >1/2 of total ESD procedure time
Time Frame
Up to 60days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histological confirmed patients(gastric adenoma or adenocarcinoma) performed gastric ESD patients about 24 hours before Exclusion Criteria: perforation after ESD piecemeal resection of ESD specimen hemostatic agent or proton pump inhibitor users before ESD heparin or antiplatelet agent users Serious concurrent infection or nonmalignant illness that is uncontrolled Psychiatric disorder that would preclude compliance Allergy history to proton pump inhibitor
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moo In Park, MD
Phone
82519905061
Email
myjuyoung@hanmail.net
Facility Information:
Facility Name
Kosin University Gospel Hospital
City
Busan
ZIP/Postal Code
602-702
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KiHwan Ku, MD
Phone
82519905209
Email
lci7ku@naver.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
11293753
Citation
Ohkuwa M, Hosokawa K, Boku N, Ohtu A, Tajiri H, Yoshida S. New endoscopic treatment for intramucosal gastric tumors using an insulated-tip diathermic knife. Endoscopy. 2001 Mar;33(3):221-6. doi: 10.1055/s-2001-12805.
Results Reference
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PubMed Identifier
9427030
Citation
Takeshita K, Tani M, Inoue H, Saeki I, Honda T, Kando F, Saito N, Endo M. A new method of endoscopic mucosal resection of neoplastic lesions in the stomach: its technical features and results. Hepatogastroenterology. 1997 Nov-Dec;44(18):1602-11.
Results Reference
background
PubMed Identifier
19922919
Citation
Goto O, Fujishiro M, Kodashima S, Ono S, Niimi K, Hirano K, Yamamichi N, Koike K. A second-look endoscopy after endoscopic submucosal dissection for gastric epithelial neoplasm may be unnecessary: a retrospective analysis of postendoscopic submucosal dissection bleeding. Gastrointest Endosc. 2010 Feb;71(2):241-8. doi: 10.1016/j.gie.2009.08.030. Epub 2009 Nov 17.
Results Reference
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PubMed Identifier
20556838
Citation
Tsuji Y, Ohata K, Ito T, Chiba H, Ohya T, Gunji T, Matsuhashi N. Risk factors for bleeding after endoscopic submucosal dissection for gastric lesions. World J Gastroenterol. 2010 Jun 21;16(23):2913-7. doi: 10.3748/wjg.v16.i23.2913.
Results Reference
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PubMed Identifier
18322872
Citation
Takizawa K, Oda I, Gotoda T, Yokoi C, Matsuda T, Saito Y, Saito D, Ono H. Routine coagulation of visible vessels may prevent delayed bleeding after endoscopic submucosal dissection--an analysis of risk factors. Endoscopy. 2008 Mar;40(3):179-83. doi: 10.1055/s-2007-995530.
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PubMed Identifier
17413293
Citation
Kim JW, Kim HS, Park DH, Park YS, Jee MG, Baik SK, Kwon SO, Lee DK. Risk factors for delayed postendoscopic mucosal resection hemorrhage in patients with gastric tumor. Eur J Gastroenterol Hepatol. 2007 May;19(5):409-15. doi: 10.1097/MEG.0b013e32801015be.
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PubMed Identifier
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Clinical Impact of Second-look Endoscopy After Endoscopic Submucosal Dissection of Gastric Neoplasm

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